Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer

Exclusion Criteria

• •Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;
• •Patient with active brain metastasis or indicated for symptomatic treatment for brain metastasis;
• •Subject receiving bisphosphonate or denosumab treatment for bone metastases was initiated within 28 days prior to study. (If the subject has received bisphosphonate or denosumab treatment prior to study and showing stable time less than 28 days,the subject is allowed to use it. Subjects who were enrolled in this study may start taking bisphosphonate or denosumab for bone metastases after the first assessment of the efficacy.
• •Patients with other primary malignancies, except cured of basal cell carcinoma skin cancer or carcinoma in situ of cervix;
• •Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody;
• •Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less);
• •Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices.
• •Patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery.
• •Patients treated with EPO, G-CSF or GM-CSF.
• •Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia); Patients occurred myocardial infarction within 6 months.
• •According to the investigator's judgment, patients have other coexisting severe and/or poorly controlled medical conditions (such as uncontrolled hypertension, uncontrolled diabetes, clotting/hemorrhagic disease, etc.).
• •Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD .
• •Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
• •Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
• •Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment;
• •Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and within 6 months after treatment;
• •Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting that there may be HIV infection, there is no need to detect);
• •Patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection);
• •Patients have alcohol or drug addiction;
• •Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator，such as inability to comply with study and/or follow-up procedures;